US drug regulators have rejected a request to use MDMA, also known as ecstasy, for treating PTSD. The FDA reviewed the drug, made by Lykos Therapeutics, to see if it could be used alongside talk therapy for mental health issues.
The FDA said no to the drug because there wasn’t enough solid evidence showing it was safe and effective. They also questioned whether the therapy combined with MDMA was necessary for treatment. The FDA asked for more studies before making a final decision.
Lykos Therapeutics expressed disappointment, especially since many people with PTSD have been waiting for new treatment options for a long time. They said more research could take years, though they are still committed to working with the FDA.
Currently, MDMA is classified as a drug with no accepted medical use and a high risk of abuse, like heroin and cannabis. The FDA’s advisers had doubts about the drug’s effectiveness and raised concerns about the study’s design and potential risks. Although the FDA often follows its advisory panel’s advice, it’s not required to do so.
In contrast, Australia has recently approved MDMA for use in therapy, showing different attitudes towards the drug’s potential benefits.
This information comes from a BBC report.
https://www.bbc.com/news/articles/c624jd9g3z3o